Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT03319160
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2017-10-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LifeVest Safety and Efficacy in Real Life Settings in France
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mosz@zoll.com', 'phone': '412-968-3333', 'title': 'Mike Osz', 'organization': 'Zoll'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Observational study. Included retrospective subjects (54%). Multiple criteria for inclusion.'}}, 'adverseEventsModule': {'timeFrame': 'Data was collected until the end of the prescribed WCD use time (typically 3 months).', 'description': 'Only serious adverse events considered related to device use were collected. Adverse events were defined as serious if it resulted in life-threatening injury/illness, required medical/surgical intervention to prevent life-threatening injury/illness or permanent impairment, required hospitalization, prolonged a hospital stay, was considered a medically important event, or resulted in death.', 'eventGroups': [{'id': 'EG000', 'title': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France\n\nWearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention', 'otherNumAtRisk': 1157, 'deathsNumAtRisk': 1157, 'otherNumAffected': 0, 'seriousNumAtRisk': 1157, 'deathsNumAffected': 26, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Inappropriate shocks', 'notes': 'Shocked without clinical VT or VF resulting in hospitalization or other medical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1157, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergy', 'notes': 'An allergy to a constituent of the LifeVest considered as medically important and required hospital stay. This was resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea with device alerts', 'notes': 'Paroxysmal dyspnea and LifeVest arrhythmia alerts resulted in hospital admission until resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Appropriate Shock Events Per Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France\n\nWearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention'}], 'classes': [{'title': 'Patients not shocked for VT or VF', 'categories': [{'measurements': [{'value': '1139', 'groupId': 'OG000'}]}]}, {'title': 'Patients with 1 appropriate shock event', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Patients with 2 appropriate shock events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Incidence per 100 patient-years', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '6.3', 'ciUpperLimit': '8.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.74', 'estimateComment': 'Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).\n\nLength of exposure: 253 patient-years.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'start to end of WCD use (3 months typical prescription)', 'description': 'Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings.\n\nFor assessing incidence per 100 patient years, all appropriate shock events were considered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Risk of Not Receiving Appropriate Shocks When Necessary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}, {'units': 'Recorded instances of VT/VF', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With VT/VF', 'description': 'All subjects who had recorded occurrences of VF or sustained VT (\\>30 seconds)'}], 'classes': [{'categories': [{'title': 'Appropriate shock for VT/VF', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Response buttons used for tolerated VT/VF', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Sustained VT, self-terminated before shock', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.', 'unitOfMeasure': 'Recorded instances of VT/VF', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Recorded instances of VT/VF', 'denomUnitsSelected': 'Recorded instances of VT/VF', 'populationDescription': 'All recorded occurrences of VF or sustained VT (\\>30 seconds)'}, {'type': 'PRIMARY', 'title': 'Inappropriate Shock Events Per Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France\n\nWearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention'}], 'classes': [{'title': 'Patients without inappropriate shock events', 'categories': [{'measurements': [{'value': '1149', 'groupId': 'OG000'}]}]}, {'title': 'Patients with 1 inappropriate shock event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Incidence per 100 patient-years', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '1.9', 'ciUpperLimit': '4.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.78', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival During WCD Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France\n\nWearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention'}], 'classes': [{'title': 'Survival to end of prescribed WCD use (WCD wearing period)', 'categories': [{'measurements': [{'value': '1132', 'groupId': 'OG000'}]}]}, {'title': 'Death during WCD wearing period', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Death after WCD wearing period', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Relative to Health State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Subjects', 'description': 'Data was collected from prospectively enrolled subjects at selected sites.'}], 'classes': [{'title': 'The LifeVest gives me peace of mind', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': "I don't worry as much because I know the LifeVest is protecting me", 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'I sleep significantly better knowing I am protected by the LifeVest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'I feel more confident returning to my normal daily activities when wearing the LifeVest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.11', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'LifeVest has given me the confidence to perform exercise or cardiac rehabilitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Wearing the LifeVest makes me take my condition seriously', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'I take significantly better care of myself since being prescribed the LifeVest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'I follow lifestyle modification recommendations from my physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'I would recommend LifeVest to family or friends with a similar medical condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time of enrollment', 'description': 'Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life.\n\nAgreement score according to 5-point Likert scale (lower is better):\n\n1. = Strongly Agree\n2. = Agree\n3. = Neither Agree nor Disagree\n4. = Disagree\n5. = Strongly Disagree', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was collected from prospectively enrolled subjects at selected sites. Not all sites participated in the quality of life surveys.\n\nResponses were available from 246 of the 529 prospectively enrolled subjects.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Causes of Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'WCD Users', 'description': 'Patients prescribed a wearable cardioverter defibrillator for:\n\n1. implantable cardiac-defibrillator (ICD) removal due to device infection,\n2. bridge to heart transplantation, or\n3. ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \\<30% in the settings of early post-myocardial infarct or after a recent coronary revascularization.'}], 'classes': [{'categories': [{'title': 'Cardiac cause', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Vascular cause (includes stroke)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Non-cardiovascular cause', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Unknown (no information available)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of prescribed device use, up to 3 months.', 'description': 'Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who died during the device prescription period. The prescriptive period ranged from 1 to 3 months.\n\nOne death had no information recorded (retrospective group) and was labeled unknown.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Deaths While Wearing the WCD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deaths While Wearing the WCD', 'description': 'Any participant who died while wearing the WCD'}], 'classes': [{'categories': [{'title': 'Arrhythmic cause: primary asystole', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Arrhythmic cause: VF (includes electrical storm)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Non-arrhythmic cause', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.', 'description': 'Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WCD Users', 'description': 'Patients prescribed a wearable cardioverter defibrillator for:\n\n1. implantable cardiac-defibrillator (ICD) removal due to device infection,\n2. bridge to heart transplantation, or\n3. ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \\<30% in the settings of early post-myocardial infarct or after a recent coronary revascularization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Data not available.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'All LifeVest users completing use between May 2014 and December 2016 were approached for retrospective enrollment.\n\nAll patients prescribed a LifeVest January 2017 through March 2018 were approached for prospective enrollment.\n\nRecruitment took place in France at 88 cardiology centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France\n\nWearable Cardioverter Defibrillator: A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '974', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Enrollment type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Prospective enrollment', 'measurements': [{'value': '529', 'groupId': 'BG000'}]}, {'title': 'Retrospective enrollment', 'measurements': [{'value': '628', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1136', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.2', 'spread': '5.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index expressed as (weight in kilograms) divided by (height in meters) squared', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing either height or weight information on 21 subjects'}, {'title': 'Resting HR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1140', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'spread': '17.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Resting heart rate as assessed by clinic personnel', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data on 17 subjects'}, {'title': 'Indication for use', 'classes': [{'title': 'ICD extraction due to infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}, {'title': 'Bridge to heart transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}]}]}, {'title': 'Early after myocardial infarction with LVEF 30% or less', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '647', 'groupId': 'BG000'}]}]}, {'title': 'Early after coronary revascularization with LVEF 30% or less', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1157', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '303', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Indications for use were based on the reimbursement policy of France at the time of the study', 'unitOfMeasure': 'Participants'}, {'title': 'LVEF (4 groups)', 'classes': [{'title': '>45%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': '>35% and ≤45%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': '>25% and ≤35%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '483', 'groupId': 'BG000'}]}]}, {'title': '≤25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '577', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 8 subjects'}, {'title': 'LVEF (3 groups)', 'classes': [{'title': '≥35%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}, {'title': '≥30% and <35%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}]}]}, {'title': '<30%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '751', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing data on 8 subjects'}, {'title': 'NYHA class', 'classes': [{'title': 'Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '797', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Class I: No limitation of physical activity. Class II: Slight limitation of physical activity due to heart failure symptoms. Class III: Marked limitation of physical activity due to heart failure symptoms.\n\nClass IV: Symptoms of heart failure at rest.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Missing information on 360 subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 1130401, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-29T13:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1164}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2017-10-19', 'resultsFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2017-10-19', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Causes of Mortality', 'timeFrame': 'Duration of prescribed device use, up to 3 months.', 'description': 'Mortality was adjudicated by 3 cardiologists into these categories: Cardiac, Vascular, or Non-cardiovascular.'}, {'measure': 'Deaths While Wearing the WCD', 'timeFrame': 'Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.', 'description': 'Deaths during device use (i.e., physically wearing the WCD) were adjudicated by 3 cardiologists as initiated by asystole, initiated by ventricular fibrillation (VF), or having non-arrhythmic causes.'}], 'primaryOutcomes': [{'measure': 'Appropriate Shock Events Per Patient', 'timeFrame': 'start to end of WCD use (3 months typical prescription)', 'description': 'Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings.\n\nFor assessing incidence per 100 patient years, all appropriate shock events were considered.'}, {'measure': 'Risk of Not Receiving Appropriate Shocks When Necessary', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (\\> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.'}, {'measure': 'Inappropriate Shock Events Per Patient', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.'}], 'secondaryOutcomes': [{'measure': 'Survival During WCD Use', 'timeFrame': 'from start to end of WCD use (3 months typical prescription)', 'description': 'The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest'}, {'measure': 'Quality of Life Relative to Health State', 'timeFrame': 'Time of enrollment', 'description': 'Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life.\n\nAgreement score according to 5-point Likert scale (lower is better):\n\n1. = Strongly Agree\n2. = Agree\n3. = Neither Agree nor Disagree\n4. = Disagree\n5. = Strongly Disagree'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sudden Cardiac Death', 'Left Ventricular Dysfunction', 'Cardiac Event', 'Cardiac Arrythmias']}, 'referencesModule': {'references': [{'pmid': '37021342', 'type': 'DERIVED', 'citation': 'Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062.'}, {'pmid': '33257972', 'type': 'DERIVED', 'citation': 'Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.'}]}, 'descriptionModule': {'briefSummary': 'This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.', 'detailedDescription': 'LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF \\<30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF \\< 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving a LifeVest prescription in clinical routine for the following indications:\n\n 1. implantable cardiac defibrillator (ICD) removal due to cardiac device infections,\n 2. a bridge to heart transplantation,\n 3. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \\<30%),\n 4. a recent coronary revascularization with LV dysfunction (LVEF \\< 30%).\n* Patients who have given their consent to participate.\n\nExclusion Criteria:\n\n\\- There are no exclusion criteria for this study'}, 'identificationModule': {'nctId': 'NCT03319160', 'acronym': 'WEARIT-FR', 'briefTitle': 'LifeVest Safety and Efficacy in Real Life Settings in France', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France', 'orgStudyIdInfo': {'id': '90D0130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All LifeVest Users', 'description': 'Patients who were prescribed and used a LifeVest in France', 'interventionNames': ['Device: Wearable Cardioverter Defibrillator']}], 'interventions': [{'name': 'Wearable Cardioverter Defibrillator', 'type': 'DEVICE', 'otherNames': ['LifeVest'], 'description': 'A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention', 'armGroupLabels': ['All LifeVest Users']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique PASTEUR', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Steve Szymkiewicz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zoll Medical Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}